Plethysmograph, Air Displacement For Body Composition Analysis
The Plethysmograph, Air Displacement For Body Composition Analysis (product code OAC) is a diagnostic device that measures total body volume and weight using air displacement plethysmography to calculate estimated body composition, including total body fat and total body lean mass. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 870.2770 within the Cardiovascular specialty. Third-party 510(k) review is available, and the device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OAC
- Device Class
- FDA class 2
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
Definition
To measure the total body volume and weight for calculating the estimated body composition (total body fat and total body lean mass).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K060848 | BOD POD | Jun 27, 2006 | Substantially Equivalent | Life Measurement, Inc. |
| K032610 | MODIFIED SONAMET BODY COMPOSITION ANALYZER | Mar 01, 2004 | Substantially Equivalent | Life Measurement, Inc. |
| K924972 | SONAMET BODY COMPOSITION ANALYZER | Feb 13, 1995 | Substantially Equivalent | Life Measurement Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.